MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Transient Ischemic Attack (2109); Cardiac Perforation (2513); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported pericardial effusion, ischemic attack and pseudoaneurysm remain unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.Concomitant device: swartz introducer.

Event Description

Related manufacturing ref: 3005334138-2021-00401.The following was published in the journal of interventional cardiac electrophysiology in an article titled ¿efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: trac-af study¿ by starek z, lehar f, jez j, et al., 05 june 2021.¿saline-irrigated radiofrequency ablation (rfa) for atrial fibrillation (af) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration.The diamondtemp (dt) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation.We sought to assess the 1-year clinical safety and efficacy of the dt catheter in treating drug-refractory paroxysmal af.The trac-af trial (nct02821351) is a prospective, single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal af.Using the dt catheter, point-by-point ablation was performed around all pulmonary veins (pvs) to achieve pv isolation (pvi).Ablation was performed in a temperature-controlled mode (60 °c, max 50 w).Acute and chronic efficacy and safety was evaluated.Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the dt catheter.Acute isolation of all pvs was achieved in 100% of patients, and freedom from af after 1 year was 70.6%.There were no steam pops, char, or coagulum on the catheter tip after ablation.One patient developed a delayed hemorrhagic pericardial effusion 8 h after the procedure, which was successfully drained, and the patient was discharged.Eleven days later, the same patient returned to the hospital for recurrence of medium-sized pericardial effusion of a sanguinolent nature that was again drained.No further accumulation occurred, and the patient did well in follow-up.One patient developed after the procedure a transient ischemic attack (impairment of vision) with complete resolution and no finding on ct of the brain.Interestingly, this patient had a cha2ds2-vasc score 0 and was treated uninterruptedly with oral anticoagulation before and after the procedure.Four patients developed pseudoaneurysm of the femoral vein.Https://doi.Org/10.1007/s10840-021-00986-0.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: AGILIS INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12016373
• MDR Text Key: 256708643
• Report Number: 3008452825-2021-00340
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention